VersaCut Handpiece

GUDID 07290109141640

LUMENIS LTD.

Tissue morcellation system handpiece, line-powered
Primary Device ID07290109141640
NIH Device Record Key17370175-9c21-4659-9972-d97f33c697a8
Commercial Distribution StatusIn Commercial Distribution
Brand NameVersaCut Handpiece
Version Model NumberVersaCut Handpiece
Company DUNS600166524
Company NameLUMENIS LTD.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
Serial Numbertrue
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone408-764-3000
Emailxxx@xxx.xxx
Phone408-764-3000
Emailxxx@xxx.xxx
Phone408-764-3000
Emailxxx@xxx.xxx
Phone408-764-3000
Emailxxx@xxx.xxx
Phone408-764-3000
Emailxxx@xxx.xxx
Phone408-764-3000
Emailxxx@xxx.xxx
Phone408-764-3000
Emailxxx@xxx.xxx
Phone408-764-3000
Emailxxx@xxx.xxx
Phone408-764-3000
Emailxxx@xxx.xxx
Phone408-764-3000
Emailxxx@xxx.xxx
Phone408-764-3000
Emailxxx@xxx.xxx
Phone408-764-3000
Emailxxx@xxx.xxx
Phone408-764-3000
Emailxxx@xxx.xxx
Phone408-764-3000
Emailxxx@xxx.xxx
Phone408-764-3000
Emailxxx@xxx.xxx
Phone408-764-3000
Emailxxx@xxx.xxx
Phone408-764-3000
Emailxxx@xxx.xxx
Phone408-764-3000
Emailxxx@xxx.xxx
Phone408-764-3000
Emailxxx@xxx.xxx
Phone408-764-3000
Emailxxx@xxx.xxx
Phone408-764-3000
Emailxxx@xxx.xxx
Phone408-764-3000
Emailxxx@xxx.xxx
Phone408-764-3000
Emailxxx@xxx.xxx
Phone408-764-3000
Emailxxx@xxx.xxx
Phone408-764-3000
Emailxxx@xxx.xxx
Phone408-764-3000
Emailxxx@xxx.xxx
Phone408-764-3000
Emailxxx@xxx.xxx
Phone408-764-3000
Emailxxx@xxx.xxx
Phone408-764-3000
Emailxxx@xxx.xxx
Phone408-764-3000
Emailxxx@xxx.xxx
Phone408-764-3000
Emailxxx@xxx.xxx
Phone408-764-3000
Emailxxx@xxx.xxx

Device Identifiers

Device Issuing AgencyDevice ID
GS107290109141640 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

GCJLaparoscope, General & Plastic Surgery

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[07290109141640]

Moist Heat or Steam Sterilization


[07290109141640]

Moist Heat or Steam Sterilization


[07290109141640]

Moist Heat or Steam Sterilization


[07290109141640]

Moist Heat or Steam Sterilization


[07290109141640]

Moist Heat or Steam Sterilization


[07290109141640]

Moist Heat or Steam Sterilization


[07290109141640]

Moist Heat or Steam Sterilization


[07290109141640]

Moist Heat or Steam Sterilization


[07290109141640]

Moist Heat or Steam Sterilization


[07290109141640]

Moist Heat or Steam Sterilization


[07290109141640]

Moist Heat or Steam Sterilization


[07290109141640]

Moist Heat or Steam Sterilization


[07290109141640]

Moist Heat or Steam Sterilization


[07290109141640]

Moist Heat or Steam Sterilization


[07290109141640]

Moist Heat or Steam Sterilization


[07290109141640]

Moist Heat or Steam Sterilization


[07290109141640]

Moist Heat or Steam Sterilization


[07290109141640]

Moist Heat or Steam Sterilization


[07290109141640]

Moist Heat or Steam Sterilization


[07290109141640]

Moist Heat or Steam Sterilization


[07290109141640]

Moist Heat or Steam Sterilization


[07290109141640]

Moist Heat or Steam Sterilization


[07290109141640]

Moist Heat or Steam Sterilization


[07290109141640]

Moist Heat or Steam Sterilization


[07290109141640]

Moist Heat or Steam Sterilization


[07290109141640]

Moist Heat or Steam Sterilization


[07290109141640]

Moist Heat or Steam Sterilization


[07290109141640]

Moist Heat or Steam Sterilization


[07290109141640]

Moist Heat or Steam Sterilization


[07290109141640]

Moist Heat or Steam Sterilization


[07290109141640]

Moist Heat or Steam Sterilization


[07290109141640]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2019-04-09
Device Publish Date2016-08-28

Devices Manufactured by LUMENIS LTD.

07290109147161 - Lumenis Pulse 120H2025-02-26
07290109147178 - Lumenis Pulse 120H2025-02-26
07290109147185 - Lumenis Pulse, Moses 2.0 (DOM)2025-02-26
07290109147192 - Lumenis Pulse 120H2025-02-26
07290109147208 - Lumenis Pulse, Moses 2.0 (INT)2025-02-26
07290109147215 - Lumenis Pulse 120H2025-02-26
07290109147222 - Lumenis Pulse 120H2025-02-26
07290109147291 - Lumenis Pulse 120H2025-02-26

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